Endoscope with guide

ABSTRACT

An instrument for use with an endoscope may include an elongate section configured to move exterior to the endoscope. The elongate section may include a distal end and a proximal end. The instrument may also include an end effector attached to the distal end of the elongate section, and an actuation device attached to the proximal end of the elongate section. The actuation device may be configured to operate the end effector. The instrument may also include a guiding member coupled to the elongate section. The guiding member may be configured to be coupled to an external surface of the endoscope to permit the guiding member to move longitudinally relative to the endoscope. The guiding member may be coupled to the elongate section such that the end effector may extend past a distal end of the endoscope and move in a transverse direction independent of the movement of the distal end of the endoscope.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is based upon and claims the benefit of priority under35 U.S.C. §119(e) of U.S. Provisional Application No. 61/129,788 toBarry Weitzner filed on Jul. 18, 2008. The entire contents of which isherein incorporated by reference.

FIELD OF THE INVENTION

Embodiments of the present invention relate to endoscopes and endoscopicinstruments with a guide on an external surface. In particular,exemplary embodiments of the present invention relate to endoscopes andendoscopic instruments that permit delivery of the instruments externalto the endoscope. Embodiments of the present invention also coversmethods of using such devices.

BACKGROUND OF THE INVENTION

An endoscope is a flexible instrument introduced into the body toexamine the inside of the body. In addition to a light source and acamera at the distal end (the end which is inside the body), typicalendoscopes may also include a plurality of lumens running therethroughfor different tasks. These lumens may include an illumination lumen,viewing lumen, irrigation lumen, aspiration lumen and one or moreworking lumens. An endoscope is introduced into the body through a bodyorifice (such as, the rectum or mouth) or a small incision. To minimizehuman discomfort and maintain flexibility of the endoscope, the diameterof an endoscope is minimized. This restriction on size of the endoscopelimits the number and size of the lumens.

Endoscopic instruments, configured to perform different diagnostic andtherapeutic tasks, may be delivered to a work site inside the bodythrough the working lumen. From its early use as a purely visualdiagnostic tool, endoscopes, along with endoscopic instruments, havegrown rapidly to provide an impressive array of therapeutic options. Theendoscope can be used for therapeutic purposes in a variety of ways. Insome instances, the endoscope serves as a means of access to anappropriate internal body part, allowing the accurate placement of adrug (or other device) on that part, using an endoscopic tool configuredfor the task. An endoscopic instrument configured for other tasks, forexample, a biopsy forceps instrument, may also be delivered to theinternal body part through the working lumen. The biopsy forcepsinstrument may be used to obtain a tissue sample from the body part (forexample, the colon). Once the tissue sample has been acquired, thebiopsy forceps instrument may be retracted out of the endoscope, and thetissue sample removed from the biopsy forceps instrument.

Endoscopic tools configured for surgical functions (incision, grasping,stitching, cauterizing, etc.) may also be delivered through the workinglumens of an endoscope to perform endoscopic surgical procedures. Inthese instances, the form of the endoscope and the associatedinstruments may impose physical limits on the surgical task that can beaccomplished. These limitations, in some cases, may restrict endoscopicprocedures from producing the same anatomical outcome as conventionalsurgery. Some of these limitations may include the small physical sizeand number of endoscopic instruments that may be delivered through theworking lumen of the endoscope, and the limited maneuverability of theworking ends of the endoscopes and endoscopic instruments. There mayalso be concerns regarding contaminating the working lumens ofendoscopes which may result in infections.

Many surgical procedures may require multiple surgical instruments atthe working site at the same time. As mentioned earlier, these surgicalinstruments are typically delivered through the working lumens of theendoscope. The limited number of working lumens in an endoscope limitsthe number of instruments that can be delivered to the surgical site ata time. Also, while it is often desirable to have larger instruments atthe surgical site, the small size of the working lumens limit the sizeof the tool that can be passed through it. This limitation on physicalsize also restricts the force that can be applied with the surgicalinstrument.

A typical endoscope may possess poor maneuverability. The working endsof a typical endoscope may be restricted to movements involvingpushing/pulling or limited torque. Similar constraints may apply toinstruments introduced via the working lumens. Effective surgery mayrequire that surgical tools possess the ability to, for example, cut andstitch precisely. These requirements may necessitate the precisemovement of endoscopic instruments in multiple dimensions. The limitedfreedom of movement of the working ends of endoscopes and endoscopictools may hinder these tasks. Ideally, the working ends of endoscopictools may be configured to move in three dimensions and converge on agiven point (a concept referred to as triangulation).

SUMMARY OF THE INVENTION

An embodiment of the invention may include an instrument for use with anendoscope. The instrument may include an elongate section configured tomove exterior to the endoscope. The elongate section may include adistal end and a proximal end. The instrument may also include an endeffector attached to the distal end of the elongate section, and anactuation device attached to the proximal end of the elongate section.The actuation device may be configured to operate the end effector. Theinstrument may also include a guiding member coupled to the elongatesection. The guiding member may be configured to be coupled to anexternal surface of the endoscope to permit the guiding member to movelongitudinally relative to the endoscope. The guiding member may becoupled to the elongate section such that the end effector may extendpast a distal end of the endoscope and move in a transverse directionindependent of the movement of the distal end of the endoscope.

Various embodiments of the invention may also include one or more of thefollowing aspects: the elongate section may be configured to rotate theend effector about one or more axes perpendicular to a longitudinal axisof the endoscope; the guiding member may be further configured to permitthe elongate section to rotate about a longitudinal axis of theendoscope; the elongate section may be configured to move relative tothe guiding member in a direction parallel to a longitudinal axis of theendoscope; the transverse direction may include two mutuallyperpendicular directions at an angle to a longitudinal axis of theendoscope; the guiding member may be slidably coupled to the elongatesection; the guiding member may be removably coupled to the elongatesection; the guiding member may be fixedly attached to the elongatesection; the guiding member may be configured to interface with afeature on the external surface of the endoscope to stop the movement ofthe guiding member along the longitudinal axis of the endoscope; theinstrument may include the endoscope.

Various embodiments of the invention may also include one or more of thefollowing aspects: the end effector may extend past the distal end ofthe endoscope by a distance between about 1 cm to 10 cm; a region of theelongate section between the guiding member and the end effector may beconfigured to move in one or more directions at an angle to alongitudinal axis of the endoscope independent of movement of the distalend of the endoscope; the guiding member may include one or more rings;the one or more rings may include a first ring configured to fit aroundthe elongate section and a second ring configured to fit around theendoscope; the one or more rings may include a hinge configured topermit one or more rings to open; the guiding member may be an integralpart of the elongate section and the guiding member may be configured tomate with a mating feature on the external surface of the endoscope toform a male and female mating connection; the mating feature may be akeyway that extends longitudinally along the endoscope; the guidingmember may be coupled to the elongate section at a distance of about 11cm to 20 cm from the end effector.

An embodiment of the invention may include a method of using anendoscopic instrument at a work site internal to a body. The method mayinclude inserting a distal end of an endoscope into the body andlocating the distal end of the endoscope proximate to the worksite. Themethod may also include coupling an endoscopic instrument to an externalsurface of the endoscope. The endoscopic instrument may have an elongatesection and an end effector attached to a distal end of the elongatesection. The endoscopic instrument may also include an actuation deviceattached to a proximal end of the elongate section to operate the endeffector. The method may further include moving the endoscopicinstrument longitudinal to the endoscope so that the end effectorextends a first distance away from the distal end of the endoscope, andoperating the endoscopic instrument at the worksite. The operating mayinclude moving the distal end of the elongate section and the endeffector in a transverse direction independent of movement of the distalend of the endoscope.

Various embodiments of the invention may also include one or more of thefollowing aspects: the first distance may be between about 1 cm to about10 cm; coupling the endoscopic instrument may include coupling a guidingmember coupled to the elongate section of the endoscopic instrument tothe external surface of the endoscope; the guiding member may be coupledto the elongate section at a second distance proximally from the endeffector so that when the guiding member is coupled to the externalsurface of the endoscope, the end effector may extend past the distalend of the endoscope by the first distance to permit the distal end ofthe elongate section and the end effector to move in one or moredirections transverse to a longitudinal axis of the endoscopeindependent of movement of the distal end of the endoscope; coupling theendoscopic instrument may further include coupling the guiding member tothe endoscopic instrument; coupling the guiding member may includepositioning a ring of the guiding member about at least a portion of theexternal surface of the endoscope; coupling the guiding member mayinclude wrapping a flexible section of the guiding member around theexternal surface of the endoscope; moving the endoscopic instrument mayfurther include rotating the endoscopic instrument around a longitudinalaxis of the endoscope; operating the endoscopic instrument may furtherinclude rotating the end effector about one or more axes perpendicularto a longitudinal axis of the endoscope; operating the endoscopicinstrument may include viewing the end effector through a viewing lumenof the endoscope.

Various embodiments of the invention may also include one or more of thefollowing aspects: coupling a second endoscopic instrument to theexternal surface of the endoscope, and the second endoscopic instrumentmay have a second end effector attached to a distal end of a secondelongate section; moving the second endoscopic instrument longitudinalto the endoscope so that the second end effector may extend a thirddistance away from the distal end of the endoscope; positioning thesecond endoscopic instrument, wherein the positioning may include movingthe distal end of the second elongate section and the second endeffector in a transverse direction independent of movement of the distalend of the endoscope; positioning the second endoscopic instrument mayinclude moving the distal end of the second elongate section and thesecond end effector in a transverse direction, independent of movementof the distal end of the endoscope, the distal end of the first elongatesection, and the first end effector; operating the endoscopic instrumentmay include viewing both endoscopic instruments through a viewing lumenof the endoscope; positioning the second endoscopic instrument mayinclude rotating the second endoscopic instrument around a longitudinalaxis of the endoscope; positioning the second endoscopic instrument mayinclude rotating the second end effector about one or more axesperpendicular to a longitudinal axis of the endoscope; the thirddistance may be between about 1 cm to about 10 cm.

An embodiment of the invention may include a medical device including anendoscope with a proximal end, a distal end, and an elongate sectionconnecting the proximal and distal ends. The medical device may alsoinclude an endoscopic instrument with an end effector at a distal end,an actuation device at a proximal end, and a shaft coupling the endeffector to the actuation device. The endoscopic instrument may extendcompletely external to the endoscope. The medical device may alsoinclude one or more guiding members. The guiding members may beimmovably coupled to the shaft and slidably coupled to the elongatesection to permit the end effector to move along a longitudinal axis ofthe endoscope. These guiding members may be coupled to the shaft suchthat the end effector may extend past the distal end of the endoscopeand move in a transverse direction independent of the movement of thedistal end of the endoscope.

Various embodiments of the invention may also include one or more of thefollowing aspects: a guiding member closest to the end effector may bepositioned between about 11 cm and about 20 cm from the end effector; atleast one of the guiding members may be integral with the shaft; themedical device may further include a stop configured to limit theextension of the end effector past the distal end of the endoscope; thestop may be on the endoscope to prevent at least one of the one or moreguiding members from sliding past the stop; the shaft may include a flexsection in a region proximate the end effector and the flex section mayenable the end effector to move in one or more transverse directionsrelative to the longitudinal axis of the endoscope.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate embodiments of the invention andtogether with the description, serve to explain the principles of theinvention.

FIG. 1 is a schematic view of an embodiment of an endoscope of theinvention performing an exemplary endoscopic surgery.

FIG. 2 is a schematic view of a distal portion of an embodiment of theendoscope of FIG. 1.

FIG. 3 is a schematic view of a distal portion of another embodiment ofthe endoscope of FIG. 1.

FIG. 4 is a schematic view of a distal portion of another embodiment ofthe endoscope of FIG. 1.

FIG. 5A-5F are cross-sectional views of various embodiments of a guideused to attach the endoscopic instrument to the endoscope of FIG. 1.

FIG. 6A is a schematic view of an embodiment of the endoscope of FIG. 1without a guide.

FIG. 6B is a cross-sectional view of the endoscope of FIG. 6A.

DESCRIPTION OF THE EMBODIMENTS

Reference will now be made to exemplary embodiments of the invention,examples of which are illustrated in the accompanying drawings. Whereverpossible, the same reference numbers will be used throughout thedrawings to refer to the same or like parts.

FIG. 1 depicts an exemplary endoscope 10 performing an exemplaryendoscopic surgery, such as transgastric gastrojejunal anastomosis. Theendoscope 10 may be inserted into the stomach 100 through the esophagus.The endoscope 10 may make an incision 80 on the stomach wall 70, passthrough the incision 80, and operate on a work site 55. The work site 55could include, for instance, part of the small intestine 50. It shouldbe emphasized that the illustrated application of the endoscope 10 inFIG. 1 is exemplary only, and that the endoscopes of the currentdisclosure may be applied to any endoscopic application known in theart.

The endoscope 10 may include an elongate member 15 extending between aproximal end 40 and a distal end 45. In the configuration depicted inFIG. 1, the proximal end 40 may include the end of the endoscope 10external to the body and the distal end 45 may include the end of theendoscope 10 internal to the body. The endoscope 10 may include a curvedexternal surface 25. The endoscope 10 may be constructed of a pluralityof materials some of which may be biocompatible. Typically, a part ofthe endoscope 10 that contacts the internal surfaces of a body may bemade substantially of a biocompatible material. In some embodiments, theexternal surface 25 of the endoscope 10 may be made substantially of alow friction biocompatible material.

The endoscope 10 may include a plurality of lumens 20 runninglongitudinally therethrough. Each lumen 20 may extend between theproximal end 40 external to the body and the distal end 45 internal tothe body. In some embodiments, the longitudinal axis of the lumens maybe substantially parallel to the longitudinal axis 12 of the endoscope10. Additionally, in some embodiments, the lumens 20 may be formedintegrally with the endoscope 10 from the proximal end 40 to the distalend 45. The lumens 20 may include one or more of, among others, anaspiration lumen, an irrigation lumen, an illumination lumen, a viewinglumen, and a working lumen. The illumination and viewing lumens mayinclude cables (such as fiber optic cables and light guides) toilluminate the work site 55, and deliver an image of the work site 55external to the body. These cables may terminate at the distal end 45 ofthe endoscope 10 at illumination devices (such as bulbs or other solidstate devices) and at imaging means (such as lens for a CCD camera). Itis also contemplated that the distal end 45 of the endoscope may includea lens and/or other devices that facilitate illumination and viewing ofthe work site 55.

Any of the lumens may have a substantially circular cross-section.However, it is also contemplated that they may have any suitable shape,size, and/or configuration. For instance, in some embodiments, the shapeof the working lumen may be configured to pass an end effector 32 of theendoscopic instrument 30 through it. The irrigation lumen may beconfigured to facilitate fluid flow therethrough, for example, from theproximal end 40 to the distal end 45. In some embodiments, the proximalend 40 of the irrigation lumen may be configured to be attached to asource of fluid. In some embodiments, the distal end 45 of theirrigation lumen may have a narrow exit. In some embodiments, thisnarrow exit may be configured in the shape of a nozzle or any otherconfiguration to alter fluid flow.

The aspiration lumen may be configured to facilitate suction and/orfluid flow therethrough. In some embodiments, the flow of fluid throughthe aspiration lumen and the irrigation lumen may be in substantiallyopposite directions. For example, fluid may flow through an irrigationlumen towards the distal end 45, while fluid flow through the aspirationlumen may be towards the proximal end 40. In some instances, theaspiration lumen may also be configured to remove biological materialfrom the distal end 45 of the endoscope 10 to the proximal end 40. Forinstance, a tissue sample along with fluid delivered to the work site 55via the irrigation lumen may be extracted out of the body through theaspiration lumen. The proximal end 40 of the aspiration channel may beconfigured to be attached to a source of suction and/or a containerconfigured, for example, to collect the tissue samples. Fluid flowthrough an irrigation lumen and an aspiration lumen may be independentlyoperated, or their operation may be coordinated to perform a function,such as the extraction of a tissue sample.

One or more endoscopic instruments 30 may protrude from the distal end45 of the endoscope 10. The endoscopic instrument 30 may pass through(and extend from) the working lumen of the endoscope 10. In someembodiments, the endoscopic instrument 30 may not pass through aninternal working lumen, but extend external to, and along side theendoscope 10. For purposes of this disclosure, extending “along side”endoscope 10 includes extending external to the endoscope 10. It is alsocontemplated that, in some embodiments, some endoscopic instruments maybe delivered through the working lumen, while other endoscopicinstruments may be delivered along side the endoscope 10. The endoscopicinstrument 30 passing along side the endoscope 10 may be secured toexternal surface 25 of the endoscope 10 using one or more guides 36.

The endoscopic instrument 30 may include a shaft 34 having an endeffector 32 attached to the distal end of instrument 30, and anactuation device (not shown) attached to the proximal end of instrument30. The end effector 32 may include a medical instrument configured toperform a task at the work site 55. In a deployed configuration, the endeffector 32 may be internal to the body proximate to the work site 55,and the actuation device may be external to the body.

The end effector 32 may include any medical instrument that may be usedin conjunction with endoscope 10. In some embodiments, the end effector32 may be a purely mechanical medical instrument (for example, biopsyforceps, baskets, graspers, snares, surgical knifes, needles, suturinginstruments, etc.), while in others, the end effector 32 may alsoinclude devices driven by an electric current (for instance, electricmotors, heating elements for cauterizing instruments, a laserlithotripter, etc.). In some embodiments, the end effector 32 may alsoinclude sensors to indicate the status of a task. These sensors mayinclude any sensors used in the art. The end effector 32 may beconstructed of one or more biocompatible materials.

The actuation device may be configured to operate the end effector 32.Operation of the end effector may include imparting motion to the endeffector 32. For instance, the actuation device may be configured tomove the end effector 32 in two dimensions along a plane perpendicularto the longitudinal axis 12 of endoscope 10 (that is, along the x-axis2, y-axis 4 directions of triad 8). In some embodiments, impartingmotion to the end effector 32 may include translating the end effector32 along the x-axis 2, y-axis 4, and z-axis 6 directions (of triad 8).In some embodiments, imparting motion to the end effector 32 may alsoinclude rotating the end effector 32 around one or more of the x-axis 2,y-axis 4, and z-axis 6 directions. Operation of the end effector 32 mayalso include imparting motion to one part of the end effector 32relative to another. That is, move different parts of the end effector32 such that the end effector 32 may perform its intended function. Forinstance, the endoscopic instrument 30 may be intended to perform thefunction of grasping a tissue sample at the work site 55. The endeffector 32 for this purpose may include a pair of jaws rotatablycoupled to each other. In such a case, the actuation device may beconfigured to rotatably move one of the jaws with respect to the othercausing the jaws to open or close. The actuation device may becontrolled manually, electronically, or by a combination of manual andelectronic means. In manual control, an endoscopist (or any humanoperator) may control the actuation device. In electronic control, theendoscopic instrument 30 may be wholly or partly controlled by acomputer (or any electronic control mechanism). In some embodiments,control of the actuation device may be based in part on feedback fromsensors incorporated in the endoscopic instrument 30.

The shaft 34 of the endoscopic instrument 30 may include an elongatedflexible section made up of one or more parts. The shaft 34 may beconfigured to operate the end effector 32 in response to actuation ofthe actuation device. For instance, in the previously stated example ofthe end effector 32 including a pair of jaws, the shaft 34 may include awire and a coil with their proximal ends connected to the actuationdevice and the distal ends coupled to the jaws. Actuation of theactuation device may move the pull wire or the coil relative to theother, causing the jaws to open and close. The actuation device and theshaft 34 may also be configured to allow the end effector to performmore complex tasks. The shaft may also include cables that transmitelectric signals to and from the end effector 32. These cables maytransmit electric signals (for example, control signals) or electricpower (for instance, power to an electric motor or a cauterizing tool)from the actuation device to the end effector 32 (or actuators/motorscoupled to the end effector 32). The cables may also transmit signals(for example, sensor signals) from the end effector 32 to the actuationdevice. The shaft 34 may also be configured to move the end effector 32in response to actuation by the actuation device. The end effector 32and the shaft 34 may be made of any biocompatible material.

To deliver an endoscopic instrument 30 with a desired end effector 32 toa work site 55 within the body, the endoscope 10 may be inserted intothe body (through a natural anatomical opening or a small incision madefor the purpose) such that the distal end 45 of the endoscope 10 isproximate to the work site 55. The endoscopic instrument 30 may now bedelivered to the worksite 55 via the endoscope 10. As mentioned earlier,the endoscopic instrument 30 may be delivered via the working lumenwithin the elongate member 15 of the endoscope 10, or along side theendoscope 10. In embodiments where the endoscopic instrument 30 isdelivered via the working lumen, the distal end of the endoscopicinstrument 30 may be placed in the working lumen and slid down theelongate member 15 (of the endoscope 10) until the end effector 32protrudes out of the distal end 45 of the endoscope 10.

In embodiments where the endoscopic instrument 30 is delivered alongside the endoscope 10, one or more guides 36 may attach the shaft 34 ofthe endoscopic instrument 30 to the external surface 25 of the endoscope10. The guides 36 may be coupled to the shaft 34 at a sufficientdistance away from the end effector 32. In certain embodiments, a guideclosest to the end effector 32 may be located between about 11 cm and 20cm from the end effector 32. In some embodiments, the guides 36 may becoupled to a location of the shaft 34 such that, when the endoscopicinstrument 30 is attached to the endoscope 10 and the end effector 32delivered to the work site 55, the end effector 32 may extend past thedistal end 45 of the endoscope 10 by a distance sufficient to permit thedistal end of the shaft 34 and the end effector 32 to move in the x andy directions. In some embodiments, the guide may be a feature, such as aprotrusion incorporated on the shaft 34 of the endoscopic instrument 30to mate with a mating keyway or a slot on the external surface 25 of theendoscope 10. In such embodiments, these features may be located suchthat the feature closest to the end effector 32 may be located betweenabout 11 cm and 20 cm from the end effector 32.

To deliver an endoscopic instrument 30 of this embodiment to the worksite 55, the guides 36 may be attached to the external surface 25 of theendoscope 10, and the endoscopic instrument 30 slid down the length ofthe endoscope 10 until the end effector 32 is located at the desiredlocation in the work site 55. As described earlier, in the deliveredconfiguration, the end effector 32 may protrude a sufficient distancebeyond the distal end 45 of the endoscope 10. In some embodiments, theend effector 32 may protrude by a distance between about 1 cm to 10 cm.It is contemplated that, in other embodiments of the device, the endeffector 32 may protrude by a different distance, for example from 0 cmto 15 cm. In some embodiments, the distance of protrusion of the endeffector 32 past the distal end 45 of the endoscope 10 may depend on thefocal length of the visual means incorporated in the endoscope 10. Theextension of the end effector 32 by a sufficient distance beyond thedistal end 45 of the endoscope 10, may enable independent freedom ofmotion to the instrument (independent from the movement of the distalend 45 of the endoscope 10) at the working end. In such a protrudingconfiguration, the endoscope's eyes (distal end of the endoscope withthe visual lumen) may be free to move independent of the hands (endeffector 32), thereby enabling the instrument to be used inside the bodywith improved dexterity.

In some embodiments, the guides 36 may be pre-attached to the endoscopicinstrument 30. In some embodiments, the guide may be a featureincorporated on the endoscopic instrument 30 to mate with the externalsurface 25 of the endoscope 10. In some other embodiments, the guides 36may be a separate part. In these latter embodiments, guides 36 may beattached to both the external surface 25 of the endoscope 10 and theshaft 34 of the endoscopic instrument (in any order), before theendoscopic instrument 30 is slid down the length of the endoscope 10.

FIG. 2 shows a schematic of an embodiment of the distal end 45 of anendoscope 10 along with an endoscopic instrument 30 delivered along sidethe endoscope 10. At least one guide 36 couples the shaft 34 of theendoscopic instrument 30 to the elongate member 15 of the endoscope 10.The guides 36 may be configured to permit relative motion between theendoscope 10 and the endoscopic instrument 30. The direction of thisrelative motion may be substantially parallel to the longitudinal axis12 of the endoscope 10, that is, along the z-axis indicated by triad 8.In some embodiments, the guides 36 may be fixedly attached to theendoscopic instrument 30 and movably attached to the external surface 25of the endoscope 10. Such an attachment may permit the guides 36 toslide on the external surface 25, while being fixedly attached to theendoscopic instrument 30. The texture of the mating surfaces of theguides 36 and the external surface 25 may be such that frictionalresistance to sliding may be minimized. In FIG. 2, arrows 65 indicatethe sliding of a guide 36 on the external surface 25. When the endeffector 32 reaches the desired location at the work site 55, a featureon the endoscope (such as a locking feature, or a stop 23) may preventfurther sliding of the guides 36. As depicted in FIG. 2, the stop 23 maybe located such that the end effector 32 may protrude the requireddistance beyond the distal end 45 of the endoscope 10.

In such an embodiment, after the one or more guides 36 are coupled tothe external surface 25 of the endoscope 10, pushing the endoscopicinstrument 30 into the body may cause the guides 36 to slide on theexternal surface 25 (as indicated by arrows 65) until the end effector32 is located at the desired location in the work site 55. In someembodiments, a sensor coupled to the end effector 32 may indicate whenend effector 32 is at the desired location. In other embodiments, atactile indication or a visual indication (including viewing via theendoscope) may be used to indicate when the end effector 32 is at thedesired location. In this embodiment, sliding of the guides 36 on theexternal surface 25 may allow the end effector 32 to move in thedirection of the z-axis 6 of triad 8. Actuation of the actuation devicemay further move the end effector 32 in the x-axis 2 and the y-axis 4 oftriad 8. The end effector may, thus, be configured to move in threedimensions at the work site 55.

In some embodiments, movement of the end effector 32 in the x-axis 2 andthe y-axis 4 may be accomplished by one or more flex sections 38 of theendoscopic instrument 30. The flex sections 38 may include a section ofthe shaft 34 that enables the end effector 32 to move in the x-axis 2and y-axis 4 directions. In some embodiments, one flex section 38 mayenable the end effector 32 to move in the x-axis 2 direction and anotherflex section 38 may enable the end effector to move in the y-axisdirection. In some embodiments, the flex sections 38 may also allow theend effector 32 to rotate around the x-axis 2, y-axis 4, and the z-axis6. As depicted in FIG. 2, the flex sections 38 in some embodiments, maybe located in the portion of the endoscopic instrument 30 that protrudesfrom the distal end 45 of the endoscope 10. Locating the flex sections38 in this manner may further the ability to move the end effector 32 ina hand like manner, thereby improving dexterity.

The flex sections 38 may include mechanical mechanisms (such as, unionjoints, gears, linkages, etc.) or electrical devices (motors, steppermotors, actuators, encoders, etc.) that enable the previously describedmovements of the end effector 32. In some embodiments, flex sections 38may also include portions of endoscopic instrument 30 of a lowerstiffness (than adjacent portions) that enable the described movements.These portions of lower stiffness may include regions of endoscopicinstrument 30 made of different materials, sizes, or shapes thanadjacent portions. It is also contemplated that flex sections 38 mayinclude smart materials or smart structures that undergo a change inshape or properties in response to an external stimulii (such as,stress, temperature, current, etc.). In some embodiments, these flexsections 38 may also include sensors (or other feedback devices) thatmay provide a signal indicative of a position of the end effector 32. Insome embodiments, the flex sections 38 are discrete sections of theshaft 34 that may be located proximate to the distal end 45 of theendoscope 10. In other embodiments, the flex sections 38 may be morespread out and may encompass a substantial portion of the shaft 34.

FIG. 3 shows a schematic of another embodiment of the distal end 45 ofan endoscope 10 along with an endoscopic instrument 30 delivered alongside the endoscope 10. In these embodiments, the guides 36 may beslidably coupled to both the shaft 34 of endoscopic instrument 30, andthe external surface 25 of the endoscope 10. In these embodiments, inaddition to the guides 36 sliding on the external surface 25 (movementindicated by arrow 65), the endoscopic instrument 30 may also slide onthe guides 36 (movement indicated by arrow 75). In such an embodiment,relative motion between the endoscopic instrument 30 and the endoscope10 (along the z-axis 6 of triad 8) may be due to a combination of theguides 36 sliding on the external surface 25 (arrow 65), and theendoscopic instrument 30 sliding on the guides 36 (arrow 75). The matingsurfaces of sliding parts may be such that only the desired level offrictional resistance is achieved.

In some of these embodiments, the sliding of the guides 36 on theexternal surface 25 (arrow 65) may occur before sliding of theendoscopic instrument 30 on the guides 36 (arrow 75). In theseembodiments, after the guides 36 are coupled to the external surface 25of the endoscope 10 (and to the shaft 34 of the endoscopic instrument30, if needed), pushing the endoscopic instrument 30 into the body maycause the guides 36 to slide on the external surface 25 (arrow 65) untilthe end effector 32 is located at the desired location in the work site55. In some embodiments, as described with respect to FIG. 2, a stop 23feature on the endoscope 10 may stop the sliding of the guide 36 whenthe end effector 32 protrudes the required distance beyond the distalend 45 of the endoscope 10.

Once the end effector 32 reaches the desired location, further movementof the end effector 32 in the z-axis 6 may be accomplished by theendoscopic instrument 30 sliding on the guide 36 (movement indicated byarrow 75). In some embodiments, movement along the z-axis may beaccomplished by both the guide 36 sliding on the external surface 25 andthe endoscopic instrument 30 sliding on the guide 36 (arrows 65 and 75).Actuation of the actuation device may further move the end effector 32along the x-axis 2 and the y-axis 4 of triad 8. As described earlier,one or more flex sections 38 may enable the end effector 32 to movealong the x-axis 2 and the y-axis 4. The end effector 32 may, thus, beconfigured to move in three dimensions at the work site 55. In someembodiments, the end effector 32 may also be configured to rotate aroundthe three axes (x-axis 2, y-axis 4, and the z-axis 6).

FIG. 4 shows a schematic of another embodiment of the distal end of anendoscope 10 along with two endoscopic instruments 30 delivered alongside the endoscope 10. As mentioned earlier, in addition to theendoscopic instruments 30 depicted in FIG. 4, other endoscopicinstruments 30 may be delivered to the work site 55 via the workinglumen and/or along side the endoscope 10. The endoscopic instruments 30may also include guides 36 that may be configured to slide on theexternal surface 25. In addition, the shafts 34 of the endoscopicinstruments 30 may also be configured to slide on the guides 36. Theguides 36 of both endoscopic instruments may also be located on therespective shafts such that the both end effectors may extend by asufficient distance from the distal end of the endoscope 10. Asmentioned earlier, extension of the end effectors from the distal end ofthe endoscope 10 may permit the distal ends of the shafts and the endeffectors to move in the x and y directions independent of the distalend 45 of the endoscope 10. In some embodiments, features on theendoscope (such as the stop 23 of FIG. 2) may be positioned to locatethe end effectors 32 at a sufficient distance from the distal end 45 ofthe endoscope 10. Flex sections 38 may also be located to enable the endeffectors 32 to move and/or rotate in the x, y, and z axes.

In some embodiments, the x-axis 2, y-axis 4, and the z-axis 6 movementsof the end effectors 32 may be coordinated to resemble the movement of ahuman hand, that is, replicate the elbow and wrist movements of a humanhand. Different embodiments of the invention may replicate the movementof the human hand to different levels. For instance, some embodiments orthe invention may substantially replicate this human hand movement,while in other embodiments, the x, y and z-axis movement of the endeffectors 32 may be less complex. The x, y, and z-axis 2, 4, and 6movement of the end effector 32 may be controlled by the actuationdevice. In some embodiments, some of the end effector 32 movements maybe substantially controlled by an automated process (for instance, usinga computer), while in other embodiments, the end effector 32 movementcontrol may be more manual. Different embodiments of the invention maydiffer in the level of automated and manual control of the end effectormovement. In some embodiments, feedback from sensors incorporated in theend effector 32 (or other parts of the endoscopic instrument 30) mayassist control of the end effector 32 movement. Other embodiments mayuse more visual (for example, provided by the viewing lumen and theendoscopic instrument 30) and/or tactile indications to control the endeffector 32 movement.

The endoscope 10 may also include one or more bendable sections 18 thatmay be configured to provide x and y-axis 2, 4 movement to the distalend 45 of the endoscopic instrument 10. Control of the x and y axismovement of the endoscope distal end may be controlled from the proximalend of the endoscope 10. Similar to the movement of the end effector 32,the x and y-axis movement of the endoscope distal end may be controlledautomatically, manually or using a combination of automatic and manualmeans. In addition to x and y-axis movement, it is also contemplatedthat in some embodiments, the flex sections 38 may permit the endoscopedistal end to move in the z-axis. The endoscope 10 may also includemechanical (gears, links, cables, etc.) and/or electrical devices(motors, actuators, etc.) configured to move the endoscope distal end inthe desired direction. It is also contemplated that in some embodiments,some (or all) of the x, y and z-axis 2, 4, 6 movement of the endoscopedistal end may be accomplished by incorporation of suitable smartmaterials (piezoelectric, electro-rheostatic, magneto-rheostatic shapememory alloys, etc.).

In some embodiments, the movement of the endoscope distal end may becoordinated with the movement of the end effector 32. This coordinationmay be accomplished automatically, manually or using a combination ofautomatic and manual means. In some embodiments, feedback from sensorsmay assist in the coordination of the movement. In some embodiments, themovement of endoscope distal end may be based on the movement of the endeffector 32 along all three dimensions (x, y and the z-axis 2, 4, 6). Insome other embodiments, the endoscope distal end movement may be basedon only movement of the end effector 32 along a certain axis (forinstance, the x and y-axis 2, 4). This coordinated movement of the endeffector 32 and the endoscope distal end may enable the work site 55 tobe well lit and visible to an operator at the proximal end 40. In someembodiments, the movement of the endoscope distal end may replicate themovement of a human head (with the viewing lumen representing the eye).As mentioned earlier, in different embodiments of the invention, theendoscope distal end may replicate the movement of the human head todifferent levels. For instance, some embodiments or the invention maysubstantially replicate the human head movement, while in otherembodiments, the x, y and z-axis movement of the endoscope distal endmay be less complex.

The ability of the endoscope distal end and the end effectors 32 to moveindependently in a coordinated manner may enable an operator to form aworking triangle between a left and a right end effector 32, and theendoscope distal end. In some embodiments, this ability may enable theoperator to simulate movements at a work site 55 internal to the bodylike the operator's movements outside the body.

As described above, guides 36 may attach endoscopic instruments 30 tothe external surface 25 of the endoscope 10. These guides 36 may beslidably attached to the endoscope 10. These guides may also be fixedlyor slidably attached to the endoscopic instrument 30. FIG. 5A throughFIG. 5F illustrate cross-sectional views of different exemplaryembodiments of the guides 36. The embodiments of the guides 36 a-36 fdepicted in FIG. 5A through 5F may be slidably attached to the endoscope10 at surface 110 a-110 f respectively, and slidably or fixedly attachedto the endoscopic instrument 30 at surface 130 a-130 f respectively. Theguides 36 a-36 f may be constructed of one or more biocompatiblematerials.

In the embodiment shown in FIG. 5A, the guide 36 a may include multiplehollow rings 105 a, 125 a. One ring 105 a may fit around the elongatesection 15 of the endoscope 10 and another ring 125 a may fit around theshaft 34 of the endoscopic instrument 30. Ring 105 a may include a hinge108 a and a lock 120 a that enables the ring 105 a to be opened to fitaround the endoscope 10. Once the ring 105 a is fit around the endoscope10, the ring 105 a may be closed and the lock 120 a engaged. It is alsocontemplated that, in some embodiments, hinge 108 a may include a livinghinge or other biasing means so that the ring 105 a may be normallyclosed. In these embodiments, the ring 105 a may be held open to fit andsnap shut around the endoscope 10. The lock 120 a may lock the opensections of the ring 105 a to prevent it from accidentally opening. Lock120 a may include any type of locking feature known in the art. Insidesurface 110 a of ring 105 a may be sufficiently lubricious to enable theguide 36 a to slide on the external surface 25.

In some embodiments, ring 125 a may also be opened and closed toremovably fit around the shaft 34 of the endoscopic instrument 30.Embodiments of the ring 125 a may also include hinge and lock mechanismsas in ring 105 a. Some of these embodiments may also include a livehinge and/or other biasing means as in the case of ring 105 a. In otherembodiments, the ring 125 a may be pre-attached to the shaft 34. Inthese cases, the endoscopic instrument 30 may have the guides 36 apermanently attached to it. In embodiments where the guides 36 a areslidably attached to the endoscopic instrument 30, the texture ofsurface 130 a may be tailored to generate only the required amount ofsliding friction. In cases where sliding of the guides 36 a on theendoscope 10 is desired before sliding of the endoscopic instruments 30on the guides 36 a, the texture of surfaces 110 a and 130 a may betailored so that the frictional resistance of surface 110 a may be lowerthan the frictional resistance of the surface 130 a.

In the embodiment of the guide 36 b shown in FIG. 5B, the ring 105 bthat fits around the endoscope 10 may be open. In such embodiments, ring105 b may snap around the elongate member 15 of endoscope 10. Thematerial of ring 105 b may be sufficiently elastic to snap over theendoscope 10 without breaking or losing its shape.

In the embodiment of the guide 36 c shown in FIG. 5C, bendable arms 105c may be bent over the endoscope 10. The material of the bendable arms105 c may be sufficiently inelastic such that they do not spring backopen.

In the embodiment of the guide 36 d shown in FIG. 5D, ring 105 d is afeature that fits on a mating track on the external surface 25 of theendoscope 10. Surface 110 d of the feature may also slide on the matingsurfaces of the track. This feature can have any shape that willfacilitate sliding on a mating track of the endoscope 10.

In the embodiment of the guide 36 e shown in FIG. 5E, ring 125 e that isattached to the endoscopic instrument 30 may be open. The guide 36 e maysnap over the endoscopic instrument 30 or may be attached to theendoscopic instrument 30 with a suitable attachment medium. In someembodiments, ring 125 e may be integrally constructed with theendoscopic instrument 30.

In the embodiment of the guide 36 f shown in FIG. 5F, ring 125 f may bea feature that fits on a mating track on the endoscopic instrument 30.It is also contemplated that other embodiments of the guide 36 f may mixand match any embodiment of ring 105 a-105 d depicted in FIGS. 5A-5Dwith any embodiment of ring 125 e-125 f depicted in FIGS. 5E-5F.

FIG. 6A shows a schematic of an embodiment of the device where the guideis a feature 136 incorporated on the shaft 34 of the endoscopicinstrument 30. FIG. 6B shows a cross-sectional view of the devicethrough plane A-A shown in FIG. 6A. A first end 150 of the feature 136may be attached to the shaft 34 of the endoscopic instrument 30 and asecond end 160 of the feature 136 may mate with a keyway 135 on theexternal surface 25 of the endoscope 10. The second end 160 may have anyshape that is configured to mate with the keyway 135. In someembodiments, the second end 160 and the keyway 135 may havecross-section shaped to resemble a T. In some embodiments, the secondend 160 may resemble a spherical knob and the keyway 135 may have asubstantially circular cross-section to mate with the spherical knob. Itis contemplated that the second end 160 may have any shape, and thecorresponding shape of the keyway 135 may include a shape configured tomate with the second end 160.

The endoscopic instrument 30 may include one or more features 136configured to mate with the keyway 135. The feature 136 may be locatedbetween about 11 cm and 20 cm from the end effector 32. In an embodimentwhere multiple features 136 may be present, the feature 136 locatedclosest to the end effector 32 may be located between about 11 cm and 20cm from the end effector 32. The distal end of the keyway 135 may alsobe positioned such that, when the endoscopic instrument 30 is attachedto the endoscope 10 and the end effector 32 delivered to the work site55, the end effector 32 may extend past the distal end 45 of theendoscope 10 by a distance sufficient to permit the distal end of theshaft 34 and the end effector 32 to move in the x and y directions. Insome embodiments, this sufficient distance may be between about 1 cm to10 cm. It is also contemplated that, in other embodiments of the device,the end effector 32 may protrude by a different distance from the distalend 45, for example from 0 cm to 15 cm.

To illustrate applications of the disclosed endoscope 10 and theendoscopic instrument 30, exemplary methods of use will now bedescribed. The distal end 45 of an endoscope 10 may be inserted throughthe mouth of a patient. The endoscope 10 may be gently pushed down thepatient's esophagus until the distal end 45 of the endoscope 10 isproximate to a work site 55 (for instance, the wall of the stomach).Proximity of the distal end 45 to the work site 55 may be identified byviewing an image from a viewing lumen of the endoscope 10, for example,displayed on a monitor. An endoscopic instrument 30 with an appropriateend effector 32 (for instance, a forceps) including pre-attached guides36 on the shaft 34 may be snapped over the external surface 25 of theendoscope 10. The endoscopic instrument 30 may now be gently pushed intothe patient's body (along the z-axis 6 indicated in FIG. 4) along sidethe endoscope 10. During insertion, it is preferable that the endeffector 32 of the endoscopic instrument 30 be in a configuration so asnot to damage internal tissue of the participant. For example, theforceps jaws may be closed and/or retracted within a sheath. Duringinstrument insertion, the guides 36 may slide on the external surface 25of the endoscope 10 to deliver the end effector 32 to the distal end 45of the endoscope 10. At the distal end 45, one or more guides 36 may beblocked from further travel by a stop 23 on the external surface 25 ofthe endoscope 10. The endoscopic instrument 30 may be rotated around thelongitudinal axis 12 of the endoscope 10 to locate the end effector 32at a suitable position.

The end effector 32 may now be moved in the x and y-axis 2, 4 directionsto bring the end effector 32 into the field of view of the visual lumen,by actuating the actuation device of the endoscopic instrument 30. Theend effector 32 may also be moved further in the z-axis 6 direction bygently pushing down the endoscopic instrument 30. Further movement ofthe end effector 32 in the z-axis 6 direction may be accomplished by theendoscopic instrument 30 sliding on the guides 36. Once the end effector32 is suitably located at the work site 55, the actuation device may beactuated to operate the end effector 32 as desired (for instance, toopen and shut the jaws of the forceps). The actuation device may beactuated to grasp and remove a tissue sample for biopsy. The endoscopicinstrument 30 may be slowly pulled out of the body to extract the tissuesample for laboratory tests.

In another embodiment, once the forceps described in the previousembodiment is located at the work site 55, another endoscopic instrument30 with a suitable end effector 32 (for instance, a cautery endeffector) may also be dispatched to the work site 55. The endoscopicinstrument 30 with a cautery end effector may be attached to theexternal surface 25 of the endoscope 10 by snapping a removable guide 36around the shaft 34 of the endoscopic instrument 30 and the externalsurface 25 of the endoscope 10. The cautery end effector may also bepositioned as desired in the work site 55 by moving the end effector inthe x, y and z-axis direction using the actuation device. More endeffectors 32 may be similarly dispatched to the work site 55 if desired.Dispatching the end effectors 32 to the work site 55 external to theendoscope 10 may allow the diameter of the endoscope 10 to be reduced.Reducing the diameter of the endoscope 10 may reduce patient discomfortand increase the flexibility of the endoscope 10 by reducing itsflexural rigidity. Since the size of the end effector 32 dispatchedexternal to the endoscope 10 may be independent of the cross-sectionalsize of the working lumen, increasing end effector size may not increasethe endoscope diameter. Dispatching end effectors 32 external to theendoscope may also reduce the likelihood of contamination of the workinglumens, and resultant spread of disease.

When all the required end effectors 32 are positioned as desired, theend effectors 32 and the endoscope distal end may be moved in the x, y,and z-axis directions by controlling the flex sections 38 of theendoscopic instruments 30, and the bendable sections 18 of the endoscope10. Controlling the individual movements of the end effectors 32 and theendoscope distal end in a coordinated manner, may allow an operator toform a working triangle between the surgical tools (cautery and forcepsend effectors), and the scope's eyes (endoscope distal end). The controland dexterity that may be permitted by the ability to move the surgicalinstruments in all three dimensions, independently and precisely, mayallow an operator to use the instruments within the body, as he may usecorresponding instruments in conventional surgery external to the body.

It will be apparent to those skilled in the art that variousmodifications and variations can be made in the disclosed systems andprocesses without departing from the scope of the invention. Otherembodiments of the invention will be apparent to those skilled in theart from consideration of the specification and practice of theinvention disclosed herein. It is intended that the specification andexamples be considered as exemplary only, with a true scope of theinvention being indicated by the following claims.

1-40. (canceled)
 41. An assembly comprising: an endoscope; and a deviceincluding: a plurality of instruments configured to be moveably coupledto opposing outer sides of the endoscope, each of the instrumentsconfigured to be selectively moved longitudinally to extend beyond adistal tip of the endoscope, each of the instruments having adeflectable distal end configured to accommodate an end effector; afeature on an external surface of the endoscope configured to stopmovement of at least one of the plurality of instruments along alongitudinal axis of the endoscope; and an actuation device attached toa proximal end of each of the instruments, each actuation device beingconfigured to independently deflect a respective one of the instrumentsinward toward the endoscope.
 42. The assembly of claim 41, wherein theplurality of instruments includes two instruments spaced 180° apart fromone another about the longitudinal axis of the endoscope.
 43. Theassembly of claim 41, wherein the each of the plurality of instrumentsare configured for triangulation.
 44. The assembly of claim 41, whereinthe actuation device attached to each of the instruments includes a pullwire.
 45. The assembly of claim 41, wherein each instrument includes alongitudinally extending flex section.
 46. The assembly of claim 45,wherein each flex section includes one or more of a union joint, a gear,a linkage, a portion of lower stiffness, or a smart material.
 47. Theassembly of claim 41, further including a guiding member configured tocouple each of the plurality of instruments to the endoscope.
 48. Theassembly of claim 47, wherein the guiding member includes a plurality ofrings.
 49. The assembly of claim 48, wherein the plurality of ringsincludes at least one ring configured to fit around one of theinstruments and a second ring configured to fit around the endoscope.50. The assembly of claim 48, wherein the guiding member includes ahinge configured to permit one or more rings to open.
 51. The assemblyof claim 50, wherein the hinge is a living hinge.
 52. A device for usewith an endoscope comprising: a plurality of instruments configured tobe moveably coupled to opposing outer sides of the endoscope, each ofthe instruments configured to be selectively moved longitudinally toextend beyond a distal tip of the endoscope, each of the instrumentshaving a deflectable distal end configured to accommodate an endeffector; an actuation device attached to a proximal end of each of theinstruments, each actuation device being configured to independentlydeflect at least one of the instruments inward toward the endoscope; anda guiding member including a plurality of rings and configured to coupleeach of the plurality of instruments to the endoscope.
 53. The device ofclaim 52, wherein the plurality of rings includes at least one ringconfigured to fit around one of the instruments and a second ringconfigured to fit around the endoscope.
 54. The device of claim 52,wherein the guiding member includes a hinge configured permit one ormore rings to open.
 55. The device of claim 54, wherein the hinge is aliving hinge.
 56. The device of claim 52, wherein the plurality ofinstruments includes two instruments spaced 180° apart from one anotherabout a central longitudinal axis of the endoscope.
 57. The device ofclaim 52, wherein the instruments are configured for triangulation. 58.An assembly comprising: an endoscope; and a device including: aplurality of instruments configured to be moveably coupled to opposingouter sides of the endoscope, each of the instruments configured to beselectively moved longitudinally to extend beyond a distal tip of theendoscope, each of the instruments having a deflectable distal endconfigured to accommodate an end effector; a feature on an externalsurface of the endoscope configured to stop movement of at least one ofthe instruments along a longitudinal axis of the endoscope; and anactuation device attached to a proximal end of each of the instruments,each actuation device being configured to independently deflect arespective one of the plurality of instruments inward toward theendoscope; and a guiding member configured to interact with the feature,the guiding member including a plurality of rings and configured tocouple each of the instruments to the endoscope.
 59. The assembly ofclaim 58, wherein the guiding member includes a hinge configured topermit at least one of the rings to open.
 60. The assembly of claim 59,wherein the hinge is a living hinge.